Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-05 @ 12:18 AM
Study NCT ID:
NCT03048994
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2012-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glutamine Supplementation in Critically Ill Patients With Severe Sepsis
Sponsor:
Changi General Hospital
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial of Glutamine Supplementation in Critically Ill Adults With Severe Sepsis: A Pilot Study
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CGH-GLU
Brief Summary:
Severe sepsis is a common condition with high mortality and morbidity. A previous meta-analysis has demonstrated the safety of glutamine supplementation with suggestion of mortality and morbidity benefits in critically ill patients. But there is lack of evidence to recommend the use of intravenous glutamine supplementation in this population group. A randomized controlled trial which is adequately powered will resolve this issue and can be included in future international nutrition guidelines for the critically ill. This pilot study is done prior to a proposed local multi-center study to investigate the effects of glutamine supplementation.
Detailed Description:
Objective
* To determine the effect of intravenous glutamine supplementation compared with placebo in critically ill patients with severe sepsis
* Primary outcome : 28 day mortality , Development of infectious complications
* Secondary outcomes
* Duration of mechanical ventilation
* Length of stay in ICU
* Length of stay in hospital
* 3 month survival status and resumption of baseline activities
* 6 month survival status and resumption of baseline activities
Study Design
* Single center, prospective, double blind, randomised controlled trial critically ill patients with severe sepsis
* Randomisation
* A centralised randomisation system at SCRI (Singapore Clinical Research institute)
* Allocation will be random and concealed, and will be blinded to everyone except the pharmacist at each site, who will be responsible for preparing and delivering them to the ICU in a blinded fashion.
* Intervention
* Patients randomised to receive glutamine supplementation will receive IV glutamine (0.5g/kg body weight/day) continuously over 24 hours.
* IV glutamine will be administered for 5 days or less if death ensues prior to 5 days or transferred to another hospital prior to 5 days. IV glutamine will be continued even if the patient is transferred outside the ICU but within the hospital.
* An intravenous saline solution that is identical in volume, color and consistency will be administered to the placebo group with the same dosing regimen and duration.
* Cointerventions
* Nutritional support will be continued as per managing ICU team discretion.
* Management of severe sepsis will be continued as per managing ICU team discretion.
* Weaning patients from mechanical ventilation will be done as per managing ICU team discretion.
* To minimise differences between centers, active dissemination of practice guidelines for nutritional support, sepsis management and weaning will be carried out.
Execution of study protocol
* The managing ICU team will be responsible in identifying patients that meet the inclusion and exclusion criteria and will inform the site research coordination
* The site research coordinator will be responsible for the following
* Obtaining consent from relatives of the patients
* Informing the site pharmacist about the recruited patients
* Follow study patients prospectively while in the ICU, hospital and post discharge at 3 and 6 months.
* Completing the case report from for each study participant
* Submitting case report forms, completed and interim reports, to coordinating statistical team
* Pharmacist
* Site pharmacist to liase with SCRI on randomised patients status (treatment vs. placebo)
* Prepare the intervention treatment and placebo
* Deliver the treatment and placebo to the respective patients.
* Nurses
* Responsible for administering the delivered medications
* Ensure and documenting compliance with administration, reasons for interruptions and documenting adverse reactions.
* Liasing with the site research coordinator daily regarding the above.
* Liasing with the site research coordinator on transfer, discharge or death of study participants
* To determine the effect of intravenous glutamine supplementation compared with placebo in critically ill patients with severe sepsis
* Primary outcome : 28 day mortality , Development of infectious complications
* Secondary outcomes
* Duration of mechanical ventilation
* Length of stay in ICU
* Length of stay in hospital
* 3 month survival status and resumption of baseline activities
* 6 month survival status and resumption of baseline activities
Study Design
* Single center, prospective, double blind, randomised controlled trial critically ill patients with severe sepsis
* Randomisation
* A centralised randomisation system at SCRI (Singapore Clinical Research institute)
* Allocation will be random and concealed, and will be blinded to everyone except the pharmacist at each site, who will be responsible for preparing and delivering them to the ICU in a blinded fashion.
* Intervention
* Patients randomised to receive glutamine supplementation will receive IV glutamine (0.5g/kg body weight/day) continuously over 24 hours.
* IV glutamine will be administered for 5 days or less if death ensues prior to 5 days or transferred to another hospital prior to 5 days. IV glutamine will be continued even if the patient is transferred outside the ICU but within the hospital.
* An intravenous saline solution that is identical in volume, color and consistency will be administered to the placebo group with the same dosing regimen and duration.
* Cointerventions
* Nutritional support will be continued as per managing ICU team discretion.
* Management of severe sepsis will be continued as per managing ICU team discretion.
* Weaning patients from mechanical ventilation will be done as per managing ICU team discretion.
* To minimise differences between centers, active dissemination of practice guidelines for nutritional support, sepsis management and weaning will be carried out.
Execution of study protocol
* The managing ICU team will be responsible in identifying patients that meet the inclusion and exclusion criteria and will inform the site research coordination
* The site research coordinator will be responsible for the following
* Obtaining consent from relatives of the patients
* Informing the site pharmacist about the recruited patients
* Follow study patients prospectively while in the ICU, hospital and post discharge at 3 and 6 months.
* Completing the case report from for each study participant
* Submitting case report forms, completed and interim reports, to coordinating statistical team
* Pharmacist
* Site pharmacist to liase with SCRI on randomised patients status (treatment vs. placebo)
* Prepare the intervention treatment and placebo
* Deliver the treatment and placebo to the respective patients.
* Nurses
* Responsible for administering the delivered medications
* Ensure and documenting compliance with administration, reasons for interruptions and documenting adverse reactions.
* Liasing with the site research coordinator daily regarding the above.
* Liasing with the site research coordinator on transfer, discharge or death of study participants
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: